Aripiprazole Pregnancy Warnings

There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in neonates exposed to antipsychotic drugs during the third trimester of pregnancy. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Animal studies have revealed evidence of developmental toxicity, including possible teratogenic effects. Congenital anomalies have been reported; however, a causal relationship has not been established. There are no controlled data in human pregnancy.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
AU TGA pregnancy category: C
US FDA pregnancy category: C
Comments:
-Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery.
-Patients should be advised to notify their physician if they are pregnant or plan to become pregnant during treatment.

Aripiprazole Breastfeeding Warnings

Use is not recommended; a decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Yes
The effects in the nursing infant are unknown.

Low levels of this drug have been detected in human milk; the maternal weight-adjusted dose calculated from 2 different women provide estimates of 0.7% and 8.3%. This drug is expected to have a minimal effect on serum prolactin levels, however 2 cases of galactorrhea have been reported.

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